Biotech Partners Advance Promising Type 1 Diabetes Treatment, Secure FDA Pre-IND Meeting Support

Biotechnology companies Kadimastem and iTolerance have reached a significant milestone in developing a potential cure for Type 1 Diabetes after completing a pre-IND meeting with the U.S. Food and Drug Administration. The companies' collaborative treatment, iTOL-102, represents a novel approach to addressing diabetes that could fundamentally transform patient care.

The investigational biologic combines Kadimastem's allogenic human stem cell-derived pancreatic islets (IsletRx cells) with iTolerance's immunomodulator technology (iTOL-100). Preclinical testing at the Diabetes Research Institute demonstrated functional insulin release and disease reversal in animal models, suggesting promising therapeutic potential.

Key to the treatment's innovation is the potential elimination of lifelong chronic immune system suppression, a significant challenge in current cell transplantation approaches. The FDA's preliminary feedback provides critical guidance for advancing the treatment, including plans for safety toxicology studies and preparation for a first-in-human clinical trial.

IsletRx offers a scalable solution to the critical shortage of donor islets, potentially providing an unlimited source of insulin-producing cells. The technology could enable precise glucose detection and insulin/glucagon production, offering hope for patients with insulin-dependent diabetes.

The pre-IND meeting represents a critical step toward potentially transformative diabetes treatment, with the companies now positioned to further develop their innovative therapeutic approach under FDA guidance.